In a recent decision of the Australian Patent Office (Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4), an opposition to the grant of Boehringer Ingelheim Vetmedica GmbH’s Standard Australian Patent Application no. 2017245601 by Zoetis Services LLC was successful on the grounds of lack of inventive step. However in contrast, a concurrent opposition to Boehringer’s Ingelheim Vetmedica GmbH’s Australian Innovation Patent no. 2020102685 was unsuccessful.[1] The Innovation Patent is a divisional of the Standard Application.
In this article, Amanda Stark and Dr Tim Fyfe discuss that despite the abolishment of the Australian innovation patent system, innovation patents are still a useful tool for Australian patentees and can provide patent protection for subject matter that does not meet the threshold of patentability required for a standard patent.
Innovation patents
Innovation patents are an Australian version of ‘a second-tier patent’ and were introduced in 2001 to encourage small and medium-sized enterprise (SMEs) to protect their innovations. Like the owners of standard patents, innovation patent owners have the exclusive rights, during the term of the patent, to exploit the invention and to authorise others to do so. The term of an innovation patent is eight years as compared with 20 years for a standard patent.
The Australian Government began the process of phasing out the innovation patent in 2020, and the last day for filing new innovation patent applications was 25 August 2021. After this date, innovation patent applications could be granted if they have a filing date in Australia of 25 August 2021 or earlier.
Importantly, pre-existing Australian patent applications or PCT applications designating Australia with a filing date of 25 August 2021 or earlier are still able to serve as the basis for a new divisional innovation patent application or be converted into an innovation patent application. All granted innovation patent rights are entitled to a normal eight-year term, however, by 26 August 2029, all innovation patents will have expired.
An innovation patent, if it meets formality requirements, will be granted shorty after filing. For an innovation patent to be enforceable, it must be examined. Examination can only occur after the innovation patent is granted (as opposed to standard patents, where examination must occur before the patent is granted). If examination is successful, the innovation patent is certified and is then enforceable. An innovation patent may be opposed at any time after it is certified.
Inventive step vs innovative step
The innovation patent system was designed to protect inventions that may not necessarily meet a higher inventive threshold required for standard Australian patents, i.e., standard patents require an inventive step for patentability, whereas innovation patents only require an innovative step.
An invention will be considered to lack an inventive step (be obvious) if the person skilled in the art faced with the same problem as the inventor, would be directly led as a matter of course to take such steps in the expectation that doing so might well produce a useful or better alternative to the prior art.[2],[3]
In contrast, the test for an innovative step does not require an advance over the prior art, and there is no requirement that the invention be non-obvious.[4],[5] Instead, what is required is a difference over the prior art that makes a substantial or real contribution to the working of the invention. According to the test, a difference of this nature may be innovative irrespective of the extent that it varies from the prior art, or the extent to which it represents an improvement over the prior art.
The Patent Examiner’s Manual of Practice and Procedure also provides useful guidance for factors in determining whether there is an innovative step:
- Does the difference identified between the invention and the prior art convey an advantage to the invention?
- Does the difference provide a technical or functional contribution to the invention?
- Is the difference a significant aspect of the operation of the invention?[6]
The technology and claims
The technology of both the Standard Application and Innovation Patent relates to methods of treating asymptomatic myxomatous mitral valve disease (MMVD) with Pimobendan. Pimobendan is a known calcium sensitiser and a selective inhibitor of phosphodiesterase 3 (PDE3) with positive inotropic and vasodilator effects, used in the management of heart failure in dogs, and is also approved for cardiovascular treatment of humans in Japan.
The claims of the Standard Application and the Innovation Patent have significant overlap.
Claim 1 of the Standard Application:
A method for treating a patient with asymptomatic (occult, preclinical) myxomatous mitral valve disease (MMVD), the method comprising administering to the patient an effective amount of a pharmaceutical composition comprising pimobendan so as to effect a reduction of the heart size of an already pathologically enlarged heart of the patient in combination with delaying the onset of clinical symptoms of heart failure in the patient.
Several days prior to the hearing, claim 1 of the Standard Application was limited from “patient” to “dogs”.
Claim 2 of the Standard Application further specifies that the MMVD is of a stage selected from the group consisting of: stage ISACHC Class IB and ACVIM stage B2.
Claim 1 of the Innovation Patent is the same as claim 2 of the Standard Application as amended.
The decision – consideration of inventive step and innovative step
Zoetis Services LLC (the Opponent) opposed the grant of Standard Patent Application no. 2017245601 (the Standard Application) and Innovation Patent no. 2020102685 (the Innovation Patent), both in the name of Boehringer Ingelheim Vetmedica GmbH (the Applicant).
As the evidence for both oppositions were essentially the same, the consideration of the two oppositions for most grounds was combined (novelty, support, clarity, sufficiency, and manner of manufacture), except for inventive step and innovative step which, as noted above, are assessed using different tests.
One of the key issues in the opposition related to the interpretation of claim outcomes i.e., the clinical outcomes provided by the method of treatment. The Opponent asserted that the defined clinical outcomes should not be considered as “standalone” features of the claims as per Otsuka v Generic Health,[7] but rather as the effects obtained by the administration of pimobendan regardless of the purpose for which the drug is being administered, and that the claim outcomes merely represent additional information about the mechanism or benefits of a known method of treatment or would be an inevitable outcome of the prior art disclosures.[8]
In contrast, the Applicant submitted that the claim outcomes cannot be read out of the claim, in line with the decision in Apotex v Sanofi-Aventis,[9] which dealt with a similar issue. The Delegate agreed with the Applicant and considered the clinical outcomes were essential features of the claims.[10]
The key piece of prior art relied on by the Opponent in both oppositions was a press release made by the Applicant (The EPIC Press Release). The difference between the claimed invention and the information provided by the EPIC Press Release was said to lay in the additional clinical outcome of the reduction of the size of an already pathologically enlarged heart, and the specific dosage regime required to achieve the effect.[11]
The standard application
The Opponent submitted that in light of the EPIC Press Release, together with the common general knowledge before the priority date, the person skilled in the art would have been directly led to try imobendane for the treatment of MMVD in dogs with left-sided heart enlargement that have not yet developed clinical signs of heart failure, in the reasonable expectation this would produce a useful result (delay of the time to onset of congestive heart failure in dogs in MMVD Stage B2).[12]
The Delegate was satisfied that evidence showed that the EPIC Press Release led veterinarians to administer pimobendan to MMVD Stage B2 dogs in the reasonable expectation that it would delay the onset of the clinical signs of congestive heart failure in that patient group, that the specific dosage amount would be derived as a matter of routine, and that the additional feature of the reduction in heart size would have been achieved. [13]
All claims of the Standard Application were found to lack an inventive step in view of the common general knowledge combined with the information provided by the EPIC Press Release.
Other grounds of opposition were unsuccessful (novelty, support, clarity, sufficiency, and manner of manufacture).
The innovation patent
The Opponent pressed grounds of lack of innovative step based on the same instances as pressed for inventive step.
Again, the Delegate considered that only two features were not taught by the EPIC Press Release: the specific dosage regime, and the additional outcome of the reduction of the size of an already pathologically enlarged heart. The Delegate determined that although the reduction of heart size would have been an inevitable outcome of the skilled person following the otherwise obvious or routine path of determining the dosage amounts in the method of treatment to delay the onset of heart failure, they would still need to determine, albeit by routine methods, the dosage regime to perform the claimed invention.[14]
Despite the Delegate considering that the specific dosage amount would be derived as a matter of routine, under the test for innovative step the relevant question to be answered was whether the additional clinical outcome i.e., reducing the size of an already pathologically enlarged heart, differs from the prior art disclosure in a manner that makes a substantial contribution to the invention.
It was the opinion of the Delegate that this outcome clearly makes a substantial technical or functional contribution and is a significant aspect of the operation of the invention over the prior art disclosures, and notwithstanding, the need to determine an appropriate dosage regimen was an additional factor that would make a functional contribution to the invention over the disclosure by the EPIC Press Release.[15] That is, the effective dosage regimen was found to be innovative.
In support of this funding, the Delegate cited Federal Court decisions in Delnorth[16] and Dura-Post[17] which previously remarked that the test for innovative step requires only a narrow comparison between the invention as claimed and the relevant prior disclosure, having regard to the fact that the threshold for an innovation patent is intended to be lower than for a standard patent.[18]
The grounds of lack of innovative step was ultimately unsuccessful, in addition to grounds of novelty, support, clarity, sufficiency, and manner of manufacture.
Key takeaways
- The innovation patent system provides patent rights for inventions which satisfy a lower threshold than that required for the granting of standard patents, due to the less onerous test of innovative step, instead of inventive step.
- The innovation patent system can provide rapid grant and robust protection in enforcement or opposition proceedings.
Although Australia’s innovation patent system will cease to exist after 26 August 2029, patentees may still secure useful patent protection via an innovation patent, under the following circumstances:
- An Australian standard patent application can be converted to an innovation application, provided the standard patent application has a filing date of or before 25 August 2021.
- An Australian divisional innovation patent application can be filed from a standard Australian patent application, provided the parent patent application has a filing date of or before 25 August 2021.
- A PCT international patent application (designating Australia) that entered national phase in Australia after 25 August 2021 can be converted to an innovation patent application, provided the PCT application has an international filing date of or before 25 August 2021.
Based on the above, innovation patents should be considered prior to enforcing a standard patent if it is vulnerable to an inventive step attack, or for filing as a divisional when a standard patent application, that is likely to be opposed, is accepted.
For more information regarding this case, or if you have questions regarding how to strategically navigate the remaining years of Australia’s innovation patent system, get in touch with us.
[1] Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4
[2] Aktiebolaget Hassle v Alphapharm Pty Ltd [2002] HCA 59; (2002) 212 CLR 411 at [50]-[53]
[3] Hood v Bush Pharmacy Pty Ltd [2020] FCA 1686 at [116]-[117]
[4] Delnorth Pty Ltd v Dura-Post (Aust) Pty Ltd [2008] FCA 1225
[5] Dura-Post (Australia) Pty Ltd v Delnorth Pty Ltd [2009] FCAFC 81
[6] Patent Manual of Practice and Procedure at 5.6.15.5.
[7] Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) (2015) 13 IPR 191, [2015] FCA 634.
[8] Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4 at [74]
[9] Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2) [2012] FCAFC 102 a
[10] Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4 at [81]
[11] Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4 at [200]
[12] Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4 at [178]
[13] Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4 at [185]
[14] Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4 at [201]
[15] Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4 at [202]
[16] Delnorth Pty Ltd v Dura-Post (Aust) Pty Ltd [2008] FCA 1225
[17] Dura-Post (Australia) Pty Ltd v Delnorth Pty Ltd [2009] FCAFC 81
[18] Zoetis Services LLC v Boehringer Ingelheim Vetmedica GmbH [2024] APO 4 at [202]
